Analytical Figures of Merit of a Dual‐Wavelength Absorbance Approach for Real‐Time Broad Protein Content Monitoring for Biomanufacturing
Abstract
Real-time in-line broad protein content monitoring in biomanufacturing downstream unit operations enables the ability to optimize and afford consistent protein recovery. Protein determination from 2 to 400 mg/mL is demonstrated herein via real-time dual-wavelength LED photometric sensor configured at 280 and 310 nm. The figures of merit of this approach include measurement accuracy within the common acceptance criteria of 100 % ± 5 with negligible bias across the linear dynamic ranges. This work expands the utility of an LED based photometric sensor for biopharmaceutical process analytical technology (PAT) applications. It is also congruent with process digitalization and automation industry 4.0 concepts underpinned by Quality by Design (QbD) principles.
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A dual wavelength LED photometric sensor configured at two wavelengths used UV absorbance to determine protein concentration during the tangential flow filtration process.
“Another study employed a dual wavelength LED photometric sensor configured at two different wavelengths, where UV absorbance was used in determining the protein concentration during the tangential flow filtration process (TFF) [79].”
From Current PAT Landscape in the Downstream Processing of Biopharmaceuticals (2025) · cites this paper as [79]
Implementing VPE systems has challenges: they are computer-controlled, can consume a significant footprint, involve various interchangeable components, and require routine cleaning and clearance verifications.
“However, there are some challenges in implementing VPE systems as they are computer‐controlled, can consume a significant footprint, involve various interchangeable components and require routine cleaning and clearance verifications [79].”
From Current PAT Landscape in the Downstream Processing of Biopharmaceuticals (2025) · cites this paper as [79]
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Current PAT Landscape in the Downstream Processing of Biopharmaceuticals
Sathiyapriyan, P., Mukherjee, S., Vogel, T., Essen, L., Boerema, D., Vey, M., & Kalina, U. (2025) · Analytical Science Advances · doi:10.1002/ansa.70013 · Cited by 45 · see citing works
- Authors
- Westwood, F., Ponstingl, M., & Dickens, J. E.
- Venue
- Journal of Pharmaceutical and Biomedical Analysis
- Publisher
- Elsevier BV
- Published
- 2024-04
- Volume
- 241
- Pages
- 115965
- ISSN
- 0731-7085
- Cited by
- 4
- References
- 0
- Language
- en
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